Speakers

European E&L Strategic Director

Hall Analytical

Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and Technical thought leadership activities.
Dr. Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written several papers and publications and is the inventor of 2 patents.
Dr. Andrew Feilden has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.

Director Senior Expert Nonclinical Safety

Bayer AG

Dr. Clemens Guenther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany, as scientist specialized for development of Transdermal Therapeutic Systems and topical Dermatological. In 2000 he became Head of Animal Pharmacokinetics within the Function of Pharmacokinetics. From 2007 to 2013, Dr. Guenther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.

After integration of the Intendis R&D platform into the Bayer Pharma R&D structure in July 2013, Dr. Guenther took over a new role as Director Nonclinical Safety Consumer Health within the Division of Bayer Pharmaceuticals. In June 2020, he became Senior Expert Nonclinical Safety within Bayer AG, R&D Pharmaceuticals. In this actual position he is still involved in the development of new chemical entities including small molecules and biological as well as the life cycle management of marketed prescribed and OTC drug products.

Meanwhile Dr. Guenther gained more than 30 years’ experience in drug development from drug discovery to post-marketing, and has successfully achieved regulatory approvals of drug products in various indications

Managing Director

Maven E&L Ltd.

Mr. Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independent consultant providing advice in the area of extractables and leachables, after working for GSK in the area of extractables and leachables since the mid 1990’s. Over that time, he has seen demand in this area grow exponentially and Jason has held roles of increasing seniority relating to the support that GSK has given to extractables and leachables (E&L).

Before setting up Maven E&L Ltd, he was the director of a team of analytical chemists who are responsible for GSK’s global R&D support for E&L activities across a wide range of product types and modalities. This included; biopharmaceutical and small molecules including Inhalation, Parenteral and Cell & Gene Therapy use. He has had the pleasure of commenting on PQRI guidelines on E&L for GSK, the E&L section in EMEA guidelines on inhalation and nasal products and co-authoring a chapter within a book entitled “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products”.

Mr. Creasey has been a member of several external groups concerned with the development of best practice guides for extractable and leachables issues these include; the IPAC-RS material working group, BPOG and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange otherwise known as ELSIE.

Currently Mr. Creasey is working and commenting on risk- based approaches to E&L requirements, which he hopes will form part of an ICH guidance in the not too distant future.

President Analytical Services

Aspen Research Corporation

Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. Dr. Roger Pearson is an industry recognized expert in Food Contact and Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.

Toxicologist

Risk Science Consortium and Former FDA

Mr. Ron Brown is an internationally known toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Mr. Brown was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee.

Prior to his position at the US FDA, Mr. Brown served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.

Mr. Brown is highly sought after as a speaker at E&L meetings in the US, Europe, and Asia and he serves on the Advisory Boards of a number of major E&L meetings.

Managing Partner & Toxicology Expert

D&B ChemTox, LLC

Managing Partner &Toxicologist

D&B ChemTox, LLC

Douglas (Doug) Ball obtained his BS and MS in Biology from St. John’s University, Jamaica, NY and is board certified in general toxicology (DABT). Doug is a full member of the American

College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, Vice President and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). He was previously employed as a toxicologist at Sandoz (now Novartis), Boehringer Ingelheim, and Pfizer. Over the past 40 years, he has assumed various project and regulatory strategy roles and is currently a Managing Partner and Toxicologist at D&B ChemTox, LLC.

Doug is a recognized expert in the evaluation and qualification of leachables and extractables (L&E) in drug products. He co-chaired a Product Quality Research Institute (PQRI) L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006) and soon to be released best practice recommendations for Parenteral and Ophthalmic Drug Products (PODP). Doug is an Expert Panel member for USP <381> Elastomeric Closures for Injection and Biocompatibility <87> and <88>, was the Pharmaceutical Research Manufacturers Association (PhRMA) Deputy Topic Lead for the International Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation Working Group (IWG) for Elemental Impurities (Q3D). Douglas Ball was a Chair and Board member of the Extractables and Leachables Safety Information Exchange (ELSIE).

Senior Principal Research Scientist

AbbVie, Inc

Greg Erexson, PhD, DABT, ATS, FRSB, ERT is a Senior Principal Research Scientist at AbbVie, Inc. in North Chicago, IL (2013-present) in Occupational and Environmental Toxicology, Preclinical Safety. He was at Abbott Laboratories, North Chicago, IL in 2012 prior to the split of Abbott into two separate companies, Abbott and AbbVie on January 2, 2013. Dr. Greg was at Baxter Healthcare in Round Lake, IL from 2006 to 2012 as aRegulatory Toxicologist primarily working in the areas of risk assessment of E&L and extraneous matter.He received both his PhD and Master’s degrees from North Carolina State University, Raleigh, NC in Toxicology and Comparative Biomedical Sciences.Dr. Greg received his Bachelor’s degree in Biology from the University of North Carolina, Chapel Hill, NC. From 2000 to 2006, He was a Manager-Study Direction at Covance Laboratories, Inc. in Vienna, VA. He was board-certified in general toxicology by the American Board of Toxicology (DABT) in 1999 and recertified in 2004, 2009 and 2014. Dr. Erexson was inducted as a Fellow in the Academy of Toxicological Sciences (ATS) in 2014 and as a Fellow in the Royal Society of Biology (FRSB)-UK in 2015. He became a European Registered Toxicologist (ERT) in 2015. He has been involved with the Extractables and Leachables Information Safety Exchange (ELSIE) consortium essentially since its inception in 2007. He is currently the chair of the ELSIE Board of Directors. He was also a member of the USP Toxicology Expert Committeefrom 2010 to 2015, former president of the Midwest Regional Society of Toxicologyand the Medical Device and Combination Product Specialty Section.Dr. Greg Erexson has authored over 90 peer-reviewed scientific publications.

Speaker Details